Shiley 4.5PEF-PRecalls & reported problems

Covidien LP · Pediatric Tracheostomy Tube Cuffless Disposable, Bedside Tray · Class 2

All models of Shiley (387)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521177215), received between Feb 1, 2022 and Feb 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Human-Device Interface Problem1

Patient problems

Bacterial Infection1
No Clinical Signs, Symptoms or Conditions1
Unintended Extubation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryFeb 1, 2022Human-Device Interface Problem; Human-Device Interface Problem
ACCORDING TO THE REPORTER, THE DEVICE HAD A LOT MORE MUCOUS PLUGGING THAN NORMAL. THE RELATIVE OF THE PATIENT HAS TO CLEAN THE SHAFT OUT AT LEAST TWO OR THREE TIMES A DAY THAT WAS UNCOMMON TO THE PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 13418874 ↗

Device details

UDI-DI	`10884521177215`
Brand	Shiley
Model	4.5PEF-P
Company	Covidien LP
Product code	JOH · Tube tracheostomy and tube cuff
Class	Class 2
FDA submission	K182861
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	Not in Commercial Distribution
Record updated	Jun 24, 2025

Device type (GMDN): Tracheostomy tube, non-reinforced, non-customized, single-use

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Other Tube tracheostomy and tube cuff devices

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Bivona 67PFSS35
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Bivona 670180
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Bivona 670170
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Shiley 6CN75R
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All Tube tracheostomy and tube cuff devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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